Auxilium Pharmaceuticals, VIVUS, Inc.'s Faster-Acting Erectile Dysfunction Drug Wins FDA Approval

Published: Sep 19, 2014

Auxilium Pharmaceuticals, VIVUS, Inc.'s Faster-Acting Erectile Dysfunction Drug Wins FDA Approval

September 18, 2014

By Jessica Wilson, BioSpace.com Breaking News Staff

VIVUS, Inc. (Nasdaq: VVUS), the Mountain View, CA-based biopharmaceutical company, and Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), the Chesterbrook, PA-based biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for STENDRA® (avanafil), a treatment for erectile dysfunction (ED). In the wake of this announcement, the stock price of VIVUS has shot up more than 12%. The stock price of Auxilium has fallen 1.5%, however, the stock surged 42% earlier this week after the company received a takeover offer from Irish drug company Endo Pharmaceuticals, so the fall could be a minor price adjustment.

A supplemental new drug application, or sNDA, can be filed, and approved, when a company wants to “make changes to drugs or their labels after they have been approved,” according to the FDA. Changes allowed include a new dosage or strength of the drug, a change in the way a company manufactures the drug, or a change in the drug’s label.

The change for STENDRA involves the ability to market the drug as an ED treatment that is effective within 15 minutes of taking the drug. “STENDRA is the first FDA-approved ED drug in nearly a decade and offers men and their partners an exciting new option,” said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals. “We believe this label expansion helps position STENDRA as an exciting 'on demand' ED treatment and assists with the very important aspect of spontaneity for men and their partners in real world use. We believe this provides a meaningful benefit for men with ED and further underscores Auxilium's commitment to being an innovative leader in men's healthcare.”

The sNDA filed by VIVUS was based on results from a randomized, double-blind, placebo-controlled evaluation of avanafil for on-demand treatment of men with ED. The study was designed to assess the efficacy of two dosage strengths of STENDRA as early as 15 minutes after dosing. A statistically significant difference between men who took STENDRA versus those who took the placebo was achieved. The endpoint was measured by the number of attempts that enabled a man to reach an erection sufficient for successful sexual intercourse as early as 15 minutes after taking the drug. The previously approved prescribing information recommended administration approximately 30 minutes before sexual activity.

The primary investigator for the clinical trial, Wayne JG Hellstrom, M.D., FACS, Professor of Urology at Tulane University School of Medicine in New Orleans, said in a press release, “ED patients in my practice are looking for a safe and effective treatment option that also works fast. In my opinion, STENDRA can be an appropriate and important treatment option because the clinical trial demonstrated that it provides a rapid onset of action in many men in as early as approximately 15 minutes.”

STENDRA (avanafil) is the only FDA-approved ED medication indicated to be taken as early as approximately 15 minutes before sexual activity. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. Auxilium Pharmaceuticals, Inc. has exclusive marketing rights to STENDRA in the U.S. and Canada.

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